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临床试验/NCT02053948
NCT02053948已完成不适用

Randomized Clinical Trial of Stoma Reversal Comparing Pursestring Wound Closure vs "Gunsight" Skin Incision and Closure Technique to Eliminate the Risk of Wound Infection

Beijing Chao Yang Hospital1 个研究点 分布在 1 个国家目标入组 143 人开始时间: 2013年11月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
143
试验地点
1
主要终点
superficial wound infection of stoma site

研究概览

简要总结

The use of temporary stomas has been demonstrated to reduce septic complications after colorectal cancer surgery, especially in high-risk anastomosis; therefore, it is necessary to reduce the number of complications secondary to ostomy takedowns, namely wound infection. The aim of this study is to compare the rates of superficial wound infection, healing time and patient satisfaction after pursestring closure vs "gunsight" skin incision and closure technique closure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • loop colostomy
  • end colostomy

排除标准

  • other stomy

研究组 & 干预措施

Pursestring Wound Closure group

Experimental

use Pursestring Wound Closure technique to close the stoma

干预措施: Pursestring Wound Closure (Procedure)

Gunsight Skin Incision and Closure group

Experimental

use Gunsight Skin Incision and Closure Technique to close the stoma

干预措施: Gunsight Skin Incision and Closure Technique (Procedure)

结局指标

主要结局

superficial wound infection of stoma site

时间窗: 1 year

次要结局

  • Healing time after stoma reversal(1 year)

研究者

发起方
Beijing Chao Yang Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhen Jun Wang

Professor

Beijing Chao Yang Hospital

研究点 (1)

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